Regulatory Resources

US FDA Regulations

Current Good Manufacturing Practices (CGMP)

US FDA - Drugs

21 CFR Part 210 21 CFR Part 211

US FDA - Medical Device

21 CFR Part 820

US FDA - Medical Device

US FDA - Dietary Supplements

Good Laboratory Practices (GLP)

Good Laboratory Practice for Nonclinical Laboratory Studies

21 CFR Part 58

Good Clinical Practices (GCP)

Investigational New Drug Application

21 CFR Part 312

Applications for FDA Approval to Market a New Drug

21 CFR Part 314

Electronic Records; Electronic Signatures

21 CFR Part 11

Regulation of Combination Products

21 CFR Part 4

Biological Products

Biological Products: General

21 CFR Part 600

Human Cells, Tissues, and Cellular and Tissue-Based Products (CGTP)

21 CFR Part 1271